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Betta Link SR Reusable Fishmouth Guide
Model 110045151 · T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · DI 10818674025826
LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2023-05-04
Z-2063-2023
Class II
Open, Classified
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
code info di
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.43
2019-02
0
2.31
2019-03
0
2.25
2019-04
0
2.08
2019-05
0
2.21
2019-06
0
2.28
2019-07
0
2.37
2019-08
0
2.23
2019-09
0
2.68
2019-10
0
2.1
2019-11
0
2.09
2019-12
0
2.29
2020-01
0
2.34
2020-02
0
2.07
2020-03
0
2.14
2020-04
0
2.25
2020-05
0
2.09
2020-06
0
2.65
2020-07
0
3.62
2020-08
0
3.36
2020-09
0
3.49
2020-10
0
4.02
2020-11
0
3.63
2020-12
0
3.57
2021-01
0
3.73
2021-02
0
3.67
2021-03
0
3.23
2021-04
0
3.49
2021-05
0
3.18
2021-06
0
3.03
2021-07
0
2.66
2021-08
0
3.22
2021-09
0
2.79
2021-10
0
2.52
2021-11
0
3.11
2021-12
0
2.67
2022-01
0
2.6
2022-02
0
3.13
2022-03
0
3.17
2022-04
0
3.52
2022-05
0
3.71
2022-06
0
2.82
2022-07
0
2.5
2022-08
0
2.59
2022-09
0
2.82
2022-10
0
3.08
2022-11
0
3.6
2022-12
0
3.74
2023-01
0
4.57
2023-02
0
3.11
2023-03
0
3.63
2023-04
0
3.08
2023-05
0
3.19
2023-06
0
3.19
2023-07
0
2.85
2023-08
0
2.89
2023-09
0
2.22
2023-10
0
2.4
2023-11
0
3.21
2023-12
0
3.04
2024-01
0
2.84
2024-02
0
3.03
2024-03
0
2.79
2024-04
0
3.59
2024-05
0
3.57
2024-06
0
3.68
2024-07
0
2.83
2024-08
0
2.74
2024-09
0
3.06
2024-10
0
3.11
2024-11
0
2.81
2024-12
0
2.56
2025-01
0
2.86
2025-02
0
4.24
2025-03
0
5.06
2025-04
0
2.79
2025-05
0
2.85
2025-06
0
2.78
2025-07
0
2.56
2025-08
0
2.6
2025-09
0
2.15
2025-10
0
2.32
2025-11
0
2.66
2025-12
0
3.79
2026-01
0
3.54
2026-02
0
3.48
2026-03
0
3.22
2026-04
0
3.13
2026-05
0
2.6
2026-06
0
3.35
This device (reports/month)Average device in LXH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION